Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05808972
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2023-03-16
Brief Title:
09 Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis
Sponsor:
Tunis University
Organization:
Tunis University
Study Overview
Official Title:
09 Sodium Chloride Versus Ringers Lactate in the Treatment of Severe Diabetic Ketoacidosis a Randomized Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Severe diabetic ketoacidosis DKA is a potentially serious complication of diabetes mellitus The treatment regimen is based on insulin and rehydration The choice of rehydration solution is a question that remains open We sought to compare the effect of sodium chloride 09 SC versus ringer lactate RL in the resolution of severe DKA as well as on the variation of electrolytes
Detailed Description:
We design an open randomized trial in adult patients admitted to our ICU for severe DKA The insulin therapy protocol was identical and the randomization concerned the rehydration solution either by SC or RL The primary endpoint was resolution of DKA at H48 defined by a composite endpoint glycemia 11 mmoll bicarbonates 15 mmoll or pH730 and anion gap 16 The secondary endpoints were resolution of DKA at H24 change in base excess to -3 meqL at 48 h and H24 and change in electrolytes insulin requirements length of stay and mortality Blood gases ionogram with chloride and lactate were performed at baseline H6 H12 H24 and H48
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None